MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Memory Loss/Impairment (1958); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving an unknown intrathecal medication via an implanted pump for spinal pain.It was reported the patient was currently in the hospital since (b)(6) 2021 because the patient was having spells where he did not know who he was, his name or his date of birth, his address, and he did not know where he was and could not walk.It was noted on (b)(6) 2021, the hospital did a ct scan and found an area by the pump they thought could be his hernia that he had fixed about 5 years ago.Now they were telling the caller they thought the patient may have infection in the area where the pump was and they want to do an mri but were concerned about doing an mri, even though the caller told them he could have an mri, but the hospital did not want to call.It was further reported the doctor felt the pump was messed up and giving the patient too much medication.The caller wanted to know how to get a rep to go to the hospital to check the pump.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a consumer via a company representative (rep) on 2021-aug-17 indicated the patient had recently reported symptoms such as confusion and amnesia.The pump was interrogated on (b)(6) 2021 and there were no alerts, logs were normal.No actions/interventions were taken to resolve the issue and the issue was not resolved at the time of this report.The patient was receiving intrathecal morphine (concentration and dose unknown).Surgical intervention was not planned and the status at the time of this report was asked but unknown.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information was received from the healthcare provider indicated that there was no device issue and that a mri was performed to rule out a granuloma.It was reported that an infection was not confirmed and that the device was functioning well.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12391577
• MDR Text Key: 268918764
• Report Number: 3004209178-2021-13133
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR